Evidence map›Paper›PMID 31425752›Full record

Trial reportThe ocular surface2020

The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease.

Munira Hussain, Roni M Shtein, Maxwell Pistilli, Maureen G Maguire, Marko Oydanich, Penny A Asbell, DREAM Study Research Group

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The ocular surface, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02128763 (Dry Eye Assessment and Management Study), which is not on this map. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02128763 phase3completednot on this map

Dry Eye Assessment and Management Study

TypeinterventionalSponsorUniversity of PennsylvaniaRan2014 to 2020Enrolled535ConditionsDry EyeArmsOmega-3 supplements, Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Pooled it
  6. Omega-3 and omega-6 polyunsaturated fatty acids for dry eye disease.The Cochrane database of systematic reviews · 2019
    Pooled it
  7. Trial
  8. Review
  9. Review
  10. Diagnostic methods for managing dry eyes.World journal of methodology · 2025
    Article
  11. Translating Biomarker Discovery: From Bench to Bedside in Dry Eye Disease.International journal of molecular sciences · 2025
    Review
  12. Insight: A Multi-Modal Diagnostic Pipeline using LLMs for Ocular Surface Disease Diagnosis.Medical image computing and computer-assisted intervention : MICCAI ... International Conference on Medical Image Computing and Computer-Assisted Intervention · 2024
    Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. NLRP3 Inflammasome as a Potential Therapeutic Target in Dry Eye Disease.International journal of molecular sciences · 2023
    Review
  18. Type 1-type 2 interferon imbalance in dry eye disease.Indian journal of ophthalmology · 2023
    Observational
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Munira HussainDepartment of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan Medical School, Ann Arbor, MI, USA.
Roni M ShteinDepartment of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan Medical School, Ann Arbor, MI, USA.
Maxwell PistilliDepartment of Ophthalmology, University of Pennsylvania, Philadelphia, PA, USA.
Maureen G MaguireDepartment of Ophthalmology, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: maguirem@pennmedicine.upenn.edu.
Marko OydanichRutgers-New Jersey Medical School, Newark, NJ, USA.
Penny A AsbellDepartment of Ophthalmology, University of Tennessee Health Science Center, Memphis, TN, USA.
DREAM Study Research Group

Funding

The Dry Eye Evaluation And Management (DREAM) Study: Coordinating CenterU10EY022879 · NEI · UNIVERSITY OF PENNSYLVANIA · PI MAGUIRE, MAUREEN G · 2013 to 2018
$7.3M
Dry Eye Evaluation and Management (DREAM) StudyU10EY022881 · NEI · UNIVERSITY OF TENNESSEE HEALTH SCI CTR · PI ASBELL, PENNY · 2013 to 2020
$2.2M
NEI NIH HHS U10 EY022879NEI NIH HHS U10 EY022881
6 · The paper itself

Abstract

purposeTo determine effects of continued or discontinued use of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among patients assigned to ω3 supplements in the first year of the DREAM study.

methodsPatients who were initially assigned to ω3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to ω3 active supplements or placebos (refined olive oil) for 12 more months. The primary outcome was change in the Ocular Surface Disease Index (OSDI) score. Secondary outcomes included change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events.

resultsAmong 22 patients assigned to ω3 and 21 to placebo supplements, the mean change in OSDI score between month 12 and 24 was similar between treatment groups (mean difference in change -0.6 points, 95% confidence interval [CI], (-10.7, 9.5), p = 0.91). There were no significant differences between groups in mean change in conjunctival staining (difference in mean change -0.5 points; 95% CI (-1.2, 0.3)), corneal staining (-0.3 points; 95% CI (-1.2, 0.3)), tear break-up time (-0.8 s; 95% CI (-2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (-2.0, 3.2)). Rates of adverse events were similar in both groups.

conclusionAmong patients who received ω3 supplements for 12 months in the primary trial, those discontinuing use of ω3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of ω3. ClinicalTrials.gov number NCT02128763.

Indexed as

Dry Eye SyndromesAdultAgedConjunctivaDietary SupplementsDouble-Blind MethodFatty Acids, Omega-3FemaleHumansMaleMiddle AgedTearsFatty Acids, Omega-3Dry eye diseaseOmega-3 fatty acidsRandomized clinical trial

Identifiers

PMID31425752
PMCPMC7004875

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.